Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021853
Company: RELIANT PHARMS
Company: RELIANT PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMACOR | OMEGA-3ACID ETHYL ESTERS | 1G | CAPSULE; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/12/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm |